UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.

About this trial

This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;

Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI <28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;

Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months;

Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;

Disqualifiers

Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;

Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs;

Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections);

Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term [≤7 days] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection);

Trial design

Design model

Parallel

Treatments tested in this trial

  • UBT251 Injection 4.0 mg

    Drug

    UBT251 Injection subcutaneously once weekly

  • UBT251 Injection 6.0 mg

    Drug

    UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly

  • UBT251 Injection Placebo 4.0 mg

    Drug

    UBT251 Injection placebo subcutaneously once weekly

  • UBT251 Injection Placebo 6.0 mg

    Drug

    UBT251 Injection placebo subcutaneously once weekly

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: UBT251 Injection 4.0 mgExperimental treatment 1 intervention
Group B: UBT251 Injection 6.0 mgExperimental treatment 1 intervention
Group C: UBT251 Injection Placebo 4.0 mgPlacebo comparator 1 intervention
Group D: UBT251 Injection Placebo 6.0 mgPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body Weight

Percentage change in body weight from baseline after 52 weeks of treatment

Time frame
Week 52

Secondary outcomes

1

Waist Circumference

Changes from baseline in waist circumference at each visit

Time frame
Through study completion, an average of one year
2

BMI

Changes from baseline in BMI at each visit

Time frame
Through study completion, an average of one year
3

Systolic blood pressure

Changes from baseline in systolic blood pressure at each visit

Time frame
Through study completion, an average of one year
4

Diastolic blood pressure

Changes from baseline in diastolic blood pressure at each visit

Time frame
Through study completion, an average of one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: